Q&A with Thelma Bueno, Sr. Clinical Project Manager at genae Americas
Q: Are there any specific pieces of information you would include in a site feasibility survey for a valve trial?
A: Depending on the type of trial we would need to know the site’s patient population and the operability risk seen in a month, for example. We also request information regarding the site’s experience with open access versus the different delivery access such as transfemoral, transapical, and others. How many patients require surgical or non-surgical valvular intervention would be another question.
Discover our other Q&A videos:
• How do you go about ensuring that a site is appropriate for a valve study?
• Are there any barriers to sites getting approved in a valve trial?
• For valve studies, please discuss some specific quirks or intricacies that prevent sites from meeting their enrollment targets?
• What unique aspects of a valve subject population make enrollment/recruitment/retention particularly difficult?
• Are there procedures specific to the conduct of a valve trial that sponsors/principal investigators should be aware of?
• Is there anything in the design of a valve trial that you foresee as a source of difficulty when it comes to executing?
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